Select Billing Location to Modify

Effective June 30, 2018, if you have not upgraded to a current browser you will no longer be able to view or make transactions on MerckVaccines.com. To protect your credit card information, Merck follows security requirements mandated by the PCI Security Standards Council. The PCI Security Standards Council has mandated that all companies that transact payments with credit cards must restrict the use of insecure browsers.

ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Select Safety Information for ZOSTAVAX® (Zoster Vaccine Live)

Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.

Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, and immunosuppressive therapy.

A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.

ZOSTAVAX has a demonstrated safety profile

In patients aged 50 to 59 years

In ZOSTAVAX Efficacy and Safety Trial (ZEST), the overall incidence of vaccine-related injection-site adverse reactions within 5 days postvaccination was greater for subjects vaccinated with ZOSTAVAX as compared to subjects who received placebo (63.6% for ZOSTAVAX and 14.0% for placebo).

Injection-site adverse reactions reported in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination in ZEST

ADVERSEREACTION

SOLICITEDa

UNSOLICITED

Pain

Erythema

Swelling

Pruritus

Warmth

Hematoma

Induration

ZOSTAVAX(n=11,094) %

53.9

48.1

40.4

11.3

3.7

1.6

1.1

PLACEBO(n=11,116) %

9.0

4.3

2.8

0.7

0.2

1.6

0.0

Injection-site reactionsa in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination from the AEMS of the SPS

ADVERSEREACTION

SOLICITEDb

Erythema

Pain/Tenderness

Swelling

ZOSTAVAX(n=3,345) %

35.6

34.3

26.1

PLACEBO(n=3,271) %

6.9

8.3

4.5

ADVERSEREACTION

UNSOLICITED

Hematoma

Pruritus

Warmth

ZOSTAVAX(n=3,345) %

1.6

6.9

1.6

PLACEBO(n=3,271) %

1.4

1.0

0.3

Injection-site adverse reactions reported in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination in ZEST

ADVERSE
REACTION

ZOSTAVAX

(n=11,094)%

PLACEBO

(n=11,116)%

Pain

53.9

9.0

Erythema

48.1

4.3

Swelling

40.4

2.8

Pruritus

11.3

0.7

Warmth

3.7

0.2

Hematoma

1.6

1.6

Induration

1.1

0.0

aSolicited on the Vaccination Report Card (VRC).

Adequate treatment provisions, including epinephrine injection (1:1,000), should be available for immediate use should an anaphylactic/anaphylactoid reaction occur.

Systemic Adverse Reactions

Systemic adverse reactions and experiences reported during Days 1 to 42 at an incidence of ≥1% in either vaccination group were headache (ZOSTAVAX 9.4%, placebo 8.2%) and pain in the extremity (ZOSTAVAX 1.3%, placebo 0.8%), respectively.

The overall incidence of systemic adverse experiences reported during Days 1 to 42 was higher for ZOSTAVAX (35.4%) than for placebo (33.5%).

Serious Adverse Events

In ZEST, serious adverse events occurred at a similar rate in subjects vaccinated with ZOSTAVAX (0.6%) or placebo (0.5%) from Days 1 to 42 postvaccination.

In ZEST, an anaphylactic reaction was reported for one subject vaccinated with ZOSTAVAX.

In patients aged ≥60 years

The Adverse Event Monitoring Substudy (AEMS) of the Shingles Prevention Study (SPS), designed to provide detailed data on the safety profile of the zoster vaccine, used vaccination report cards (VRC) to record adverse events occurring from Days 0 to 42 postvaccination.

Injection-site reactionsb in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination from the AEMS of the SPS

ADVERSEREACTION

SOLICITEDc

UNSOLICITED

Erythema

Pain/Tenderness

Swelling

Hematoma

Pruritus

Warmth

ZOSTAVAX(n=3,345) %

35.6

34.3

26.1

1.6

6.9

1.6

PLACEBO(n=3,271) %

6.9

8.3

4.5

1.4

1.0

0.3

Injection-site reactionsb in ≥1% of adults who received ZOSTAVAX or placebo within 5 days postvaccination from the AEMS of the SPS

ADVERSE
REACTION

ZOSTAVAX

(n=3,345)%

PLACEBO

(n=3,271)%

Erythema

35.6

6.9

Pain/Tenderness

34.3

8.3

Swelling

26.1

4.5

Swelling

1.6

1.4

Pruritus

6.9

1.0

Warmth

1.6

0.3

bPatients instructed to report adverse experiences on the VRC.

cSolicited on the VRC.

Most injection-site adverse reactions were reported as mild in intensity.

Systemic Adverse Reactions

Headache was the only systemic adverse reaction reported on the VRC between Days 0 to 42 by ≥1% of subjects in the AEMS in either vaccination group (ZOSTAVAX 1.4%, placebo 0.8%).

Serious Adverse Events

From Day 0 to 42 postvaccination, in the overall study population, serious adverse experiences (SAEs) occurred at a similar rate (1.4%) in subjects vaccinated with ZOSTAVAX or placebo. In the AEMS,b the rate of SAEs was increased in the group who received ZOSTAVAX (1.9%) as compared to the placebo group (1.3%) from Day 0 to 42 postvaccination.

Over the course of the entire study, in the overall study population, investigator-determined, vaccine-related SAEs were reported for 2 subjects vaccinated with ZOSTAVAX (asthma exacerbation and polymyalgia rheumatica) and 3 subjects who received placebo (Goodpasture's syndrome, anaphylactic reaction, and polymyalgia rheumatica).

Among reported SAEs in the SPS (Days 0 to 42 postvaccination), serious cardiovascular events occurred more frequently in subjects who received ZOSTAVAX (20 [0.6%]) than in subjects who received placebo (12 [0.4%]) in the AEMS.b

The frequencies of serious cardiovascular events were similar in subjects who received ZOSTAVAX (81 [0.4%]) and in subjects who received placebo (72 [0.4%]) in the entire SPS cohort (Days 0 to 42 postvaccination).

About ZOSTAVAX

ZOSTAVAX is a live attenuated virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older. ZOSTAVAX is not indicated for the treatment of zoster or postherpetic neuralgia. ZOSTAVAX should not be used for prevention of primary varicella infection (Chickenpox).

Select Safety Information for ZOSTAVAX® (Zoster Vaccine Live)

Vaccination with ZOSTAVAX does not result in protection of all vaccine recipients.

Do not administer ZOSTAVAX to individuals who are immunodeficient or immunosuppressed due to disease or therapy, as serious or fatal disseminated vaccine strain varicella-zoster virus disease may occur. Causes of immunodeficiency or immunosuppression may include, but are not limited to, primary or acquired immunodeficiency states, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, leukemia, lymphoma or other malignant neoplasms affecting the bone marrow or lymphatic system, and immunosuppressive therapy.

A reduced immune response to ZOSTAVAX was observed in individuals who received concurrent administration of PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) and ZOSTAVAX compared with individuals who received these vaccines 4 weeks apart. Consider administration of the two vaccines separated by at least 4 weeks.